HERBRAND PharmaChemicals GmbH
Form 483 issued December 9, 2022 · Gengenbach, Germany
- Inspection
- Dec 5 – Dec 9, 2022
- Investigator
- Nicole E. Knowlton
- Observations
- 3
- Pages
- 2
- FEI number
- 3003310388
In short: On December 9, 2022, FDA issued a Form 483 with 3 observations to HERBRAND PharmaChemicals GmbH in Gengenbach, Germany (FEI 3003310388) after an inspection that ran Dec 5 – Dec 9, 2022. The investigator was Nicole E. Knowlton. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no assurance that all laboratory test procedures are scientifically sound and appropriate to ensure…
- 02
There is no assurance the pages in the batch production records ioc are the original pages…
- 03
The list of minor deviations is maintained on a spreadsheet that is not validated and the…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmHERBRAND PharmaChemicals GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HERBRAND PharmaChemicals GmbH?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected HERBRAND PharmaChemicals GmbH?
Nicole E. Knowlton is named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was HERBRAND PharmaChemicals GmbH inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for HERBRAND PharmaChemicals GmbH?
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